UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002310 |
|---|---|
| Receipt number | R000002816 |
| Scientific Title | Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis. |
| Date of disclosure of the study information | 2009/08/31 |
| Last modified on | 2014/03/27 18:02:31 |
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Basic information
Public title
Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Acronym
Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients. (GBCRG-2surg-01)
Scientific Title
Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Scientific Title:Acronym
Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients. (GBCRG-2surg-01)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Endocrine surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of adjuvant chemotherapy combined with docetaxel and cyclophosphamide for breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
completion rate
Key secondary outcomes
Disease free survival
Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
four cycles of therapy, administered every 3 weeks.
Docetaxel (75 mg/m2) and Cyclophosphamide (600 mg/m2) are administered by intravenous infusion on day 1 in eacn cycle.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically diagnosed breast cancer without lymph node metastasis or with three and under lymph node metastasis.
2)Age 20 to 70 years
3)ECOG PS 0 to 2
4)Previous endocrine therapy or chemotherapy for breast cancer.
5)Required baseline laboratory parameters
6)Without severe complications,ischemia attack, uncontrolled congestive heart failure
7)Written informed consent
Key exclusion criteria
1)Patients who received previous endocrine therapy or chemotherapy
2)Severe drug allergic history
3)Inflammatory breast cancer
4)Bilateral breast cancer in same time
5)Severe complications
6)Active double cancer
7)Inflammation with fever up
8)Neurological problem
9)Pleural effusion or pericardial effusion
10)Symptomatic brain metastasis
11)Pregnancy
12)Severe edema
13)Interstitial lung disease, pulmonary fibrosis
14)Psychiatric disease
15)Doctors decision for excluion
16)Low risk in St. Gallen Conferences 2007
17)16 weeks or more after operation
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nana Rokutanda |
Organization
Gunma University Graduate School of Medicine
Division name
Thoracic Visceral Organ Surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL
027-220-8245
nana.rokutanda@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nana Rokutanda |
Organization
Gunma Breast Cancer Research Group 2 surgery (GBCRG-2surg) 01
Division name
Secretariat Division (Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Scho
Zip code
Address
3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL
027-220-8245
Homepage URL
nana.rokutanda@gmail.com
Sponsor or person
Institute
Gunma Breast Cancer Research Group 2 surgery
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Visceral Organ Surgery ,
Gunma University Graduate Schol of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2009 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 09 | Day |
Last modified on
| 2014 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002816
